An Open-Label, MultiCenter Evaluation of the Use of Topic... | NCT01105793 | Trialant

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An Open-Label, MultiCenter Evaluation of the Use of Topic... | NCT01105793 | Trialant

Studies
An Open-Label, MultiCenter Evaluation of the Use of Topically Administered FP1198 in Subjects With Pain Associated With Cyclic Mastalgia

NCT01105793

Sponsor

FemmePharma Global Healthcare, Inc.

Status

Completed

Last Update Posted

Oct 26, 2011Estimated

Enrollment

20Estimated

Phase

Phase 2

Conditions

Moderate to Severe Cyclic Mastalgia

Interventions

Danazol

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

NCT01105793

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

FP1198-002

Secondary IDs

Not provided

Brief Title

An Open-Label, MultiCenter Evaluation of the Use of Topically Administered FP1198 in Subjects With Pain Associated With Cyclic Mastalgia

Official Title

Not provided

Acronym

Not provided

Organization

FemmePharma Global Healthcare, Inc.INDUSTRY

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

No

Start Date

Jun 2010

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Apr 13, 2010

First Submission Date that Met QC Criteria

Apr 15, 2010

First Posted Date

Apr 16, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2011

Last Update Posted Date

Oct 26, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

FemmePharma Global Healthcare, Inc.INDUSTRY

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

No

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine the safety of topical FP1198 for the treatment of moderate to severe cyclic breast pain (cyclic mastalgia) and to examine the clinical activity of FP1198.

Detailed Description

Not provided

Conditions Module

Conditions

Moderate to Severe Cyclic Mastalgia

Keywords

cyclic mastalgia
cyclic breast pain
fibrocystic breast disease

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Danazol	Drug	High dose FP1198 applied once daily to both breasts for 6 treatment cycles.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in breast pain		six months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

menstruating females at least 18 years of age
BMI less than 30
moderate to severe breast pain associated with the menstrual cycle
in good general health

Exclusion Criteria:

pregnant within the last 6 months
has taken in the last 3 months or currently taking hormonal contraception
history of malignancy or currently being treated for cancer of the breast or genital organs
has had breast implants or breast reduction surgery

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Women's Health Care		San Diego	California	92123	United States
Horizons Clinical Research

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

Non-Randomized

Intervention Model

Single Group Assignment

Intervention Model Description

Not provided

Primary Purpose

Treatment

Observational Model

Not provided

Time Perspective

Not provided

Masking Info

Masking

None (Open Label)

Masking Description

Not provided

Who Masked

Not provided

Denver

Colorado

80220

United States

Kentucky Medical Research Center

Lexington

Kentucky

40504

United States

Salt Lake Research

Salt Lake City

Utah

84107

United States

ID	Term
D005348	Fibrocystic Breast Disease

Ancestor Terms

ID	Term
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D003613	Danazol

Ancestor Terms

ID	Term
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided